Access to medicines and health services are vital for the Asian region, especially since this region has the largest share of the world's people, stated the participants at the Asian Regional Workshop on 'WTO TRIPS Agreement and Access to Medicines: Appropriate National Policy Responses' organised by the Third World Network and Health Action International (Asia Pacific) with the cooperation of UNDP, WHO, Medicine Sans Frontier and Consumer Project on Technology in Kuala Lumpur on 28-30 November 2004.
The workshop was attended by 90 participants including policy makers, representatives and experts from health movements, NGOs from countries in the region: Bangladesh, Cambodia, China, Fiji, Hong Kong, India, Indonesia, Laos, Malaysia, Papua New Guinea, Myanmar, Pakistan, Philippines, South Korea, Sri Lanka, Thailand, Vietnam and international agencies. Other participants came from Ghana, Australia, France and Switzerland.
Participants at the workshop noted that the globalization process has had an impact on health care. Women, children and the elderly are among the most affected. There was also concern expressed over the loss of purchasing power among the impoverished that worsened access to medicines and health care.
The workshop heard presentations and discussed the relationship between patents, prices and access to medicines. Data on prices of various products within and across Asian countries were presented by resource persons showing that prices of branded products are significantly (and often greatly) higher than similar generic products, and also that the presence of generics brings down the prices of branded products in the same country. Countries that do not have access to generics pay much higher prices than those that do have such access for the same products. It is therefore essential that patented drugs do not enjoy monopoly and that competition from generics should be enabled, so that the patients have more choice and prices can be brought down. Many participants also called for price controls to be placed by governments on medicines since these are essential items.
The workshop also discussed how the TRIPS Agreement, by requiring patentability of medicines under certain minimum standards, has constrained the ability of governments to institute pro-health policies, such as the exclusion of medicines from patentability, which some Asian countries had done prior to the coming into force of TRIPS. The Doha Declaration has clarified that there are some flexibilities and safeguards including the ability of governments to implement measures such as compulsory licensing, government use/rights and parallel importing, to offset the monopoly of patents.
Many participants asked that governments undertake a serious review process of TRIPS so as to expand the policy flexibilities in TRIPS, for example to consider that countries are enabled to exclude patents on medicines and food. Several speakers pointed out that before TRIPS, countries had excluded medicines from patentability, for example in the India Patent Act 1970.
In the immediate term, governments are urged to urgently review their patent laws and amending them to bring them in line with the best options and provisions possible, especially in light of the Doha Declaration on TRIPS and Public Health. The patent laws should enable the country to provide compulsory licenses, government use orders and parallel importing in simple and effective ways. The governments in the region should then exercise their rights by taking these measures required to treat ailments. The workshop recommended that the Manual on Good Practices in Public Health Oriented Patent Policies and Laws and its supplement (published by TWN) be used as a key reference point for review of policies and laws.
The participants expressed concern and also anxiety whether there will be continued and expanded supply of medicines to countries that have no or inadequate manufacturing capacity. This arises from a constraint in TRIPS Article 31(f) that production under compulsory license has to supply predominantly for the domestic market, thus limiting export supply. The "interim solution" to this through the WTO's 30 August 2003 decision was found by participants to be impractical for dealing with this problem. Many participants pointed out that the measures required, such as notification of amounts of drugs and special labeling and packaging, on top of the issuing of compulsory licenses, will most likely deter generic drug producers from making use of this mechanism. They called for a more appropriate permanent solution that revises TRIPS and that removes the Article 31(f) constraint without placing new constraints so that the export and import of generic drugs can be smoothly facilitated.
The participants were concerned about the post-2005 situation since an important generic-producing country, India, has to start allowing drug product patent applications, under its TRIPS obligation. Participants urged that the proposed amendments to the India Patent Act 1970 should be made in ways that take full advantage of the rights and flexibilities of the TRIPS agreement and the Doha Declaration, and that obligations that are not required by TRIPS (that are i.e. TRIPS-plus) need not be included. Many participants signed a joint letter drafted during the workshop to the President and Prime Minister of India to this effect. The participants also hope and expect that the relevant Indian authorities will establish systems that enable applications for compulsory licenses to be rapidly processed and acted on. It was emphasized that it is critical that the supply of generic drugs from India should not be reduced or hampered, including to African countries, in the new post-2005 situation.
The workshop heard presentations on the nature of the bilateral free trade agreements that have been concluded, for example between the US and many countries or regions around the world, and of similar agreements that are currently being negotiated, for example with Thailand. Participants were extremely concerned that many aspects of the IPR chapters of these agreements removed or eroded the flexibilities available in TRIPS and the Doha Declaration. The FTAs for example seek to extend the lifespan of drug patents, establish exclusive rights over test data (which would prevent generic products from being registered) and restrict the grounds for compulsory licenses. These negative traits are likely to appear in FTAs that Asian countries are negotiating with the US, unless the governments are alert and reject such TRIPS-plus proposals. The participants expressed support for the Thai movements and NGOs that are working to ensure that the US-Thai FTA does not include such negative traits, and pledged to undertake activities to prevent such negative traits in other bilateral or regional FTAs.
The workshop discussed issues and processes related to drug regulation and registration and good practices in procurement of drugs. It was stressed that all drugs distributed (whether by innovators or generic producers) should meet the requirements of quality, safety and efficacy. Presentations in the workshop clarified that the TRIPS Agreement does not require that exclusive rights be granted over the test data submitted for the approval of the originator drugs. There was concern among participants that a major developed country is attempting to have Asian countries accept that exclusive rights over test data be granted to the originator drug company, through FTAs. Participants expressed the view that this would have extremely damaging effects on access to medicines, as this would block the implementation of supply (through import or production) of generic drugs to compete with originator drugs including those that are not patented in the country. A presentation was also made about good practices in negotiations with companies to reduce prices during the procurement exercise. The WHO's system of prequalification was recognized as an important mechanism for countries to choose medicines that meet the safety and efficacy tests; the system should be improved further to suit the needs of developing countries.
Some participants also brought up the problem posed by the patenting of life forms and the protection of intellectual property regarding plant varieties, which arose from Article 27.3(b) of the TRIPS Agreement. They urged that patenting of life-forms should be prohibited and that the seeds and other genetic resources of farmers should not be subjected to patenting or IP protection having similar effects. As this affects food security and access to food, it is also a health issue.
Three working groups were convened to discuss the situation of individual countries with regard to their policy on access to medicines, patent law and patent law amendment, safeguard measures and generic production. A plenary session to receive reports from these groups heard the present status of the countries, and many suggestions on what can and should be done. A session was also held on "the way forward" for Asian countries on making progress on providing access to medicines.